FDA.reportPublic FDA data

Orthopaedic cement, medicated

Definition
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.
GUDID devices
21
Last updated
2019-07-22 23:17:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20603295174261NADEPUY (IRELAND)5450-31-5002015-09-24
20603295174278NADEPUY (IRELAND)5450-32-5002015-09-24
20603295174285SMARTSETDEPUY (IRELAND)5450-35-5002015-09-24
20603295174292SMARTSETDEPUY (IRELAND)5450-50-5012015-09-24
04260102136083PALACOS®Heraeus Medical GmbHfast R+G2019-06-13
28031497000491Cemex Genta LVTECRES SPA1400/AG US2015-10-06
28031497000507Cemex Genta HVTECRES SPA1400/IG US2015-10-06
14260056885676BonOs R Genta 1x40OSARTIS GmbH01-02172015-09-25
24260056885765Simplex HV with GentamicinOSARTIS GmbH6195-1-0012015-09-24
37613327128421SimplexHowmedica Osteonics Corp.6197-9-0012017-06-19
37613327128452SimplexHowmedica Osteonics Corp.6192-1-0012017-06-19
00855195006241Unite CementOSTEOREMEDIES, LLCUNITE402016-01-20
00855195006494Remedy SpacerOSTEOREMEDIES, LLCUNITE402016-04-06
00880304476783Cobalt MV with GentamicinBiomet Orthopedics, LLC4024392015-11-28
00880304560796Cobalt HV with GentamicinBiomet Orthopedics, LLC4022832015-11-28
00880304990197Refobacin® Bone Cement RBIOMET1100343552018-03-30
00880304990203REFOBACIN® BONE CEMENT RBIOMET1100343562018-03-30
00880304990210REFOBACIN® BONE CEMENT RBIOMET1100343572018-03-30
00880304990227REFOBACIN® BONE CEMENT RBIOMET1100343582018-03-30
00885556582220RALLYSmith & Nephew, Inc.712715702015-10-08
00885556582237RALLYSmith & Nephew, Inc.712715902015-10-08